The device must be designed & manufactured in such a way that, when used under the conditions & for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety & health of users or, where applicable, other persons, provided associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health & safety.

2.

The solutions adopted by the manufacturer for the design& construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.

In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:

-where appropriate take adequate protection measures including alarms, if necessary, in related to risks that cannot be eliminated

-inform users of the residual risks due to any shortcomings of the protection methods adopted.

3.

The devices must achieve the performance intended by the manufacturer and be designed, manufactured & packaged in such a way that they are suitable for one or more of the functions referred to as specified by the manufacturer.

4.

The characteristics & performances referred to in sections 1,2 & 3 must not be adversely affected to such a degree that the clinical condition & safety of the patients & where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.

5.

The devices must be designed, manufactured & packed in such a way that their characteristics & performances during their intended use will not be adversely affected during transport & storage taking account of the instructions & information provided by the manufacturer.

6.

Any undesirable side effects must constitute an acceptable risk when weighed against the performances intended.

7.

7.1

DESIGN ANDMANUFACTURING REQUIREMENTS

Chemical, physical & biological properties

The devices must be designed & manufactured in such a way as to guarantee the characteristics & performance referred to in Section 1 on the “ General Requirements” Particular attention must be paid to:

-the compatibility between the materials used and biological tissues, cells& body fluid, taking account of the intended purpose of the device;

7.2

The devices must be designed, manufactured & packed in such a way as to minimise the risk posed by contaminants & residues to the persons involved in the transport, storage & use of the devices & to the patients, taking account of the intended purpose of the product.

Particular attention must be paid to the tissues exposed & the duration & frequency of the exposure.

7.3

The devices must be designed & manufactured in such a way that they can be used safely with the materials, substances& gases with which they enter into contact during normal use or during routine procedures; if they are intended to administer medicinal products they must be designed & manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing those products and that their performance is maintained in accordance with the intended use.

7.4

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product & which is liable to act upon the body with action ancillary to that of the device, the safety, quality & usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods

7.5

The devices must be designed & manufactured in such a way as to reduce as much possible, risks posed by the unintentional ingress of substances into the device taking into account the device & the nature of the environment in which it is intended to be used.

8.

8.1

Infection & microbial contamination

The devices & their manufacturing processes must be designed in such a way as to eliminated or reduce as far as is possible the risk of infection to the patient, user & third parties, the design must allow easy handling and, where necessary, minimise contamination of the device by the patient or vice versa during use.

8.2

Tissues of animal origin must originate from animals that have been subjected to veterinary controls & surveillance adapted to the intended use of the tissues. Notified Bodies shall retain information on the geographical origin of the animals.

Processing, prevention, testing & handling of tissues, cells & substances of animal origin must be carried out so as to provide optimal security. In particular, safety with regard to viruses & other transferable agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process.

8.3

Devices delivered in a sterile state must be designed, manufactured and packed in a non- reusable pack and/or according to appropriate procedures to ensure that they are sterile when placed on the market & remain sterile, under the storage & transport conditions laid down, until the protective packaging is damaged or opened.

8.4

Devices delivered in a sterile state must have been manufactured & sterilised by an appropriate, validated method.

8.5

Devices intended to be sterilised must be manufactured in appropriately controlled (e.g. environmental) conditions.

8.6

Packaging systems for non-sterile devices must keep the product without deterioration in the level of cleanliness stipulated and, if the devices are to be sterilised prior to use, minimise the risk of microbial contamination. The packaging system must be suitable taking account of the method of sterilisation indicated by the manufacturer.

8.7

The packaging and/or label of the device must distinguish between identical or similar products sold in sterile and non- sterile condition.

9.

9.1

Manufacturing and environmental properties

If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must specified performance of the devices. Any restrictions on use must be indicated on the label or instruction for use.

9.2

Devices must be designed & manufactured in such a way as to remove or minimise as far as possible:

-the risk of injury, in connection with their physical features, including the volume/ pressure ratio, dimension, and where appropriate the ergonomic features,

-the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given,

-risks arising where maintenance or calibration are not possible (as with implants) from ageing of the materials used or loss of accuracy of any measuring or control mechanism.

9.3

Devices must be designed & manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use included exposure to flammable substance which could cause combustion.

9.4

Devices must be designed and manufactured in such a way as to facilitate the safe disposal of any waste

10.

10.1

Devices with a measuring function.

Devices with a measuring function must be designed & manufacturedin such a way as to provide sufficient accuracy & stability within appropriate limits of accuracy & taking account of the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer.

10.2

The measurement, monitoring & display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device.

10.3

The measurements made by devices with a measurements made by devices with a measuring function must be expressed in legal units conforming to the metric system.

11.

11.1

11.1.1

Protection against radiation

General

Devices shall be designed & manufactured such that exposure of patients, users& other persons to radiation shall be reduced as far as possible compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic & diagnostic purposes.

11.2

11.2.1

Intended radiation

Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it must be possible for the user to control the emissions. Such devices shall be designed & manufactured to ensure reproducibility & tolerance of relevant variable parameters.

11.2.2

Where devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must be fitted, where practicable, with visual displays and/or audible warning of such emissions.

11.3

11.3.1

Unintended radiation

Devices shall be designed & manufactured in such s way that exposure of patients, users and other persons to theemission if unintended, stray or scattered radiation must be reduced as far as possible.

11.4

11.4.1

Instructions

The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting the patient and the user and on ways of avoiding misuse & of eliminating the risks inherent in installation.

11.5

11.5.1

Ionising radiation

Devices intended to emit ionising radiation must be designed & manufactured in such a way as to ensure that, where practicable, the quantity, geometry and quality of radiation emitted can be varied & controlled taking account of the intended uses.

11.5.2

Devices emitting ionising radiation intended for diagnostic radiology shall be designed & manufactured in such a way as to achieve appropriate image and/or output quality for the intended medical purpose whilst minimising radiation exposure of the patient and user.

11.5.3

Devices emitting ionising radiation, intended for therapeutic radiology shall be designed & manufactured in such a way as to enable reliable monitoring & control of the delivered dose, the beam type & energy & where appropriate the quality of the radiation.

12.

12.1

Requirements for medical devices connected to or equipped with an energy source.

Devices incorporating electronic programmable systems must be designed to ensure the repeatability & performance of these systems according to their intended use. In the event of a single fault condition ( in the system) appropriate means should be adopted to eliminate or reduce as far as possible consequent risks.

12.2

Devices where safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply.

12.3

Devices where the safety of the patient depends on an external power supply must include an alarm system to signal any power failure.

12.4

Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient’s state of health.

12.5

Devices must be designed & manufactured in such a way as to minimise the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment.

12.6

12.6.1

Protection against electrical risks

Devices must be designed & manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during normal use& in single fault condition, provided that the devices are installed correctly.

12.7

12.7.1

Protection against mechanical & thermal risks

The devices must be designed and manufactured in such a way as to protect the patient & user against mechanical risks connected with, for example, resistance, stability & moving parts.

12.7.2

The devices must be designed & manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress & of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.

12.7.3

The devices must be designed & manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress & of the means available to reduce noise, particularly at source, unless the emitted is part of the specified performance.

12.7.4

The terminals& connectors to the electricity, gas or hydraulic & pneumatic energy supplies which the user has to handle must be designed & constructed in such a way as to minimise all possible risks.

12.7.5

Accessible parts of devices (excluding any parts or areas intended to supply heat or reach given temperatures) & their surroundings must not attain potentially dangerous temperatures under normal use.

12.8

12.8.1

Protection against the risks posed to the patient by energy supplies or substances

Devices for supplying the patient with energy or substances must be designed & constructed in such a way that the flow rate can be set & maintained accurately enough to guarantee the safety of the patient & the user.

12.8.2

Devices must be fitted with the means of preventing and/or indicating any inadequacies in the flow –rate which could pose a danger.

Devices must incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an energy and/or substance source.

12.9

The function of the controls & indicators must be clearly specified on the devices.

Where a device bears instructions required for its operation or indicates operation or adjustment parameters by means of a visual system, such information must be understandable to the user &, as appropriate, the patient.

13.

13.1

Information supplied by the manufacturer

Users should be provided with the information needed to identify the manufacturer, to use the device safely and to ensure the intended performance, taking account of their training and knowledge. This information should be easily understood.

All data generated in support of performance evaluation should be obtained in accordance with the relevant requirements applicable

14.2

Clinical investigation on human subjects should be carried out in accordance with the spirit of the Helsinki Declaration. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results. In addition, some countries may have specific regulatory requirements for pre-study protocol review or informed consent

I declare that the information provided in this form is accurate and correct and the device conforms to all applicable requirements stipulated above.